A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000748

Collaborator

Glaxo Wellcome (Industry)

2,500

Enrollment

Locations

104.2

Patients Per Site

Study Details

Study Description

Brief Summary

To compare the safety and efficacy of two dosage regimens (daily and thrice-weekly) of sulfamethoxazole/trimethoprim (SMX/TMP; TMS) in the prevention of Pneumocystis carinii pneumonia (PCP) in high-risk HIV-infected patients.

Previous tests have shown that SMX/TMP given daily is effective in preventing recurrence of PCP and may be effective in preventing PCP in patients who have never developed it. Because SMX/TMP can cause side effects, this study will attempt to determine the safest and most effective dose of this combination.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia, Pneumocystis Carinii HIV Infections	Drug: Sulfamethoxazole-Trimethoprim	Phase 3

Detailed Description

Patients receive SMX/TMP orally on a daily or thrice-weekly basis. Patients are clinically evaluated every 4 months. Patients on daily SMX/TMP who develop a drug-related toxicity may be switched to thrice-weekly SMX/TMP. Duration of follow-up is 12 months.

Study Design

Study Type:

Interventional

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients

Actual Study Completion Date :

Nov 1, 1996

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patients must have:

HIV infection.
CD4 count <= 200 cells/mm3 OR a history of prior PCP.
No active pneumocystosis. Patients or their guardians must sign informed consent. Pregnant patients are eligible at the clinician's discretion. Patients who do not meet required laboratory values may be eligible at the discretion of the clinician.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

Known treatment-limiting reaction to sulfonamides or trimethoprim.

Concurrent Medication:

Excluded:

Other PCP prophylaxis or medication with anti-PCP activity.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Community Consortium of San Francisco	San Francisco	California	United States	94110
2	Stanford Univ School of Medicine	Stanford	California	United States	94305
3	Denver CPCRA / Denver Public Hlth	Denver	Colorado	United States	80204
4	Wilmington Hosp / Med Ctr of Delaware	Wilmington	Delaware	United States	19899
5	Veterans Administration Med Ctr / Regional AIDS Program	Washington	District of Columbia	United States	20422
6	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
7	AIDS Research Alliance - Chicago	Chicago	Illinois	United States	60657
8	Louisiana Comm AIDS Rsch Prog / Tulane Univ Med	New Orleans	Louisiana	United States	70112
9	Baltimore Trials	Baltimore	Maryland	United States	21201
10	Univ of Maryland at Baltimore	Baltimore	Maryland	United States	21201
11	Comprehensive AIDS Alliance of Detroit	Detroit	Michigan	United States	48201
12	Henry Ford Hosp	Detroit	Michigan	United States	48202
13	Southern New Jersey AIDS Cln Trials / Dept of Med	Camden	New Jersey	United States	08103
14	North Jersey Community Research Initiative	Newark	New Jersey	United States	07103
15	Partners Research	Albuquerque	New Mexico	United States	87131
16	Univ Hosp / HIV - ID Clinic	Albuquerque	New Mexico	United States	87131
17	Bronx Lebanon Hosp Ctr	Bronx	New York	United States	10456
18	Addiction Research and Treatment Corp	Brooklyn	New York	United States	11201
19	Clinical Directors Network of Region II	New York	New York	United States	10011
20	Harlem AIDS Treatment Group / Harlem Hosp Ctr	New York	New York	United States	10037
21	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon	United States	97210
22	Philadelphia FIGHT	Philadelphia	Pennsylvania	United States	19107
23	Richmond AIDS Consortium	Richmond	Virginia	United States	23298
24	Univ of Washington / Pacific Med Ctr	Seattle	Washington	United States	98144